Regulatory Education for Industry (REdI) Annual Conference
July 19 – 23, 2021
Featuring three medical product center tracks:
Drugs, Devices, and Biologics
Learn directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FDA’s regulatory requirements.
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The Agenda above may be updated if any changes are made. The current version is Version 9, updated on July 17, 2021 |
The speaker biographies document contains detailed information for the Conference speakers. |
Session Recordings:
Links to recordings will be added here as they become available.
- Day One Sessions:
- Keynote Address by Janet Woodcock, MD
- Plenary Session with Patrizia Cavazzoni, MD
- OND Reorganization and the New Drugs Regulatory Program Modernization
- ANDA Efforts Related to COVID-19
- Resource Capacity Planning: How CDER is Modernizing Resource Planning Capabilities
- CDER NextGen Portal
- Electronic Common Technical Document (eCTD)
- Product Quality Consideration for Emergency Use Authorizations (EUAs)
- Strategies to Address Potential Medication Errors for EUA Products for COVID-19
- Clinical Pharmacology Regulatory Sciences in Drug Development and Precision Medicine
- Day Two Sessions:
- CDER’s Role in Public Health Emergency Response and Medical Countermeasure Development
- Where Do We Go from Here? How the Ombudsman Can Help
- Communication Best Practices – Interacting with Regulatory Project Managers in CDER/ORO
- Communications in a Global Pandemic
- Regulatory Policy: Role in Guiding Decision Making in CDER
- Role of the Product Jurisdiction Team in the Medical Product Development Process
- FDA Guidance on Conduct of Clinical Trials of Medical Products During the Public Health Emergency
- OSI’s Role in the Drug Development Process and Impact of COVID-19
- Recording of Livestream from Day Three (Devices)
- Recording of Livestream from Day Four (Devices and Biologics)
- Recording of Livestream from Day Five (Biologics)
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More Information
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